ClinicalTrials.gg
Status unknownNCT03443037Updated Sep 6, 2018

Benefits of Amantadine in Patients With Coma State

An observational study in Coma; Prolonged and Amantadine, sponsored by Dokuz Eylul University. Status unknown at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-09-06.

Sponsored by Dokuz Eylul University · Observational

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
56
Ages
18 Years to 65 Years
Sex
All
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Study summary

The study was a single center observational-prospective study and approved by local ethics committee. Patients in coma state due to traumatic brain injury, cardiac arrest or ischemic stroke who are older than 18 years of age were included in the study. Patients who received amantadine 200mg/day for fourteen days according to ICU protocols decided by primary physician formed the amantadine group, and the rest of the subjects were included in the control group. All patients were evaluated for Glasgow Coma Score, JFK Coma Recovery Scale and Disability Rating Scale once a week for three months.

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Conditions studied

  • Coma; Prolonged
  • Amantadine

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Keywords

  • Coma
  • Disability
  • amantadine
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In context

Coma

138 studies on the registry are indexed under Coma; 35 are open to participants now.

This study's planned enrollment of 56 is below the median of 100 across 58 observational studies indexed under Coma.

Browse Coma studies →

Lead sponsor

Dokuz Eylul University is the lead sponsor of 261 studies on the registry; 35 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with the coma state duo to ischemic stroke, brain hemorhage, anoxic brain damage included in this study.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 years, ≤ 65 years
  • GCS score ≤ 8
  • Coma state due to ischemic stroke, brain hemorhage, anoxic brain damage

Exclusion criteria

Exclusion Criteria:

  • \<18 years, > 65 years
  • Patients admitted to the critical care without diagnosis of coma state
  • Patients admitted to critical care with coma state that are not duo to ischemic stroke, brain hemorhage, anoxic brain damage
  • malignant neoplazm
  • Congenital or acquired brain function problem (cerebral palsy, autism etc)
  • Patients with amantadine allergy
  • Progressive degenerative diseases (Alzheimer, Parkinson diseases etc)
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
56 participants (estimated)
Patient registry
No

Groups and cohorts

  • Amantadine group

    Patients admitted to the critical care with diagnosis of coma state who have received amantadin 200 mg / day for fourteen days according to İCU protocols decided by primary physician

    Drug: amantadine sulphate

  • Control group

    Patients admitted to the critical care with diagnosis of coma state who haven't received amantadin

Interventions

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What researchers measure

Primary outcomes

  1. Change in Glascow Coma Score

    Glascow Coma Score

    Time frame: 1. At the time of enrollment 2. 12 weeks after the enrollment

07

Study locations

1 of 1 sites recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2016 (actual). Primary completion is estimated for Jul 2019, 40 months after the start.

Of 24 observational studies under Coma, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 60. This study's planned 40 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 16, 2018
First posted
Feb 22, 2018
StartActual
Mar 1, 2016
Primary completionEst.
Jul 1, 2019
CompletionEst.
Jul 1, 2019
Last update
Sep 6, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 6, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03443037
Responsible party
Begum Ergan (Staff in the department of pulmonary and critical care medicine, Dokuz Eylul University) — Principal investigator
First posted
Feb 22, 2018
Start date
Mar 1, 2016
Primary completion
Jul 1, 2019 (estimated)
Completion
Jul 1, 2019 (estimated)
Last update
Sep 6, 2018

Study contacts

Kutlay Aydin, MD
Contact
kutlayaydin@hotmail.com
+905322649294
Necati Gokmen, MD
study chair · Dokuz Eylul University
Kutlay Aydin
principal investigator · Dokuz Eylul University
Kutlay Aydin
study director · Dokuz Eylul University
Begum Ergan
principal investigator · Dokuz Eylul University

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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Discussion

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